📂 ISO 13485 Quality Management System

International Harmonization, Quality Assurance and Sustainability for Medical Device Manufacturers

For companies operating in the medical device sector, ISO 13485:2016 is an internationally recognized quality management system standard. This standard mandates the establishment and maintenance of quality assurance systems throughout the design, manufacture, distribution, and sale of medical devices.

Era Management provides expert consulting services for establishing a quality management system (QMS) compliant with ISO 13485 and integrating existing systems with the standard. With our experienced team, we develop customized solutions, taking into account the specific needs of the medical device industry.

Our Scope of Services

  • ›Evaluation of existing systems for compliance with ISO 13485:2016 (GAP analysis)
  • ›Quality management system design in accordance with ISO 13485 standard.
  • ›Establishing the documentation structure (procedures, instructions, forms, etc.)
  • ›Integration of risk management and traceability processes.
  • ›Planning and conducting internal audits.
  • ›Structuring management review processes
  • ›Trainings (ISO 13485 awareness, internal auditor, etc.)
  • ›Certification process preparation and audit support services.

Why ISO 13485?

  • ✓Compliance with regulatory requirements such as MDR (EU 2017/745) and FDA.
  • ✓Quality infrastructure is essential for accessing global markets.
  • ✓Improving process efficiency and product safety.
  • ✓Gaining customer trust and brand reputation

✅ Why Era Management?

●Specialization in the healthcare sector
●Expert team
●Experience in national and international projects
●Strong collaborations with certification bodies.
●Strong communication
●Solution-oriented
●Customized project team
●Company memory
●A simplified, sustainable, and implementable system setup approach.

Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

Get More Information

For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

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